Compliance – Our Commitment for Quality and Security

Trust Through Verified Standards Standards

Our organization is committed to the highest standards of quality, information security, and data protection. To ensure transparency and traceability, we rely on internationally recognized certifications. Below is an overview of our most important compliance certificates:

Quality Management

ISO 13485 – Quality Management for Medical Devices

ISO 13485 is the globally recognized standard for quality management systems in the field of medical devices. It applies to all companies that develop, manufacture, distribute, or provide services related to medical devices. The certification confirms that our processes meet legal requirements and ensure the safety and effectiveness of our products. This is a key prerequisite for the approval and market launch of medical devices, particularly within the European market. Special emphasis is placed on risk management and compliance with regulatory requirements.

Information Security

ISO/IEC 27001 – Information Security Management

ISO 27001 is the international standard for establishing, implementing, and continuously improving an Information Security Management System (ISMS). The certification demonstrates that we systematically protect sensitive data and information, identify risks at an early stage, and implement appropriate security measures. This includes clear policies, defined responsibilities, risk management, and regular audits.

ISO 27017 – Information Security for Cloud Computing

With ISO 27017, we extend our ISMS to include specific requirements for information security in cloud environments. This standard is aimed at both providers and users of cloud services and defines additional security controls to address the unique risks of cloud computing. Certification is based on ISO 27001 and ensures that our cloud services meet the highest security standards.

ISO 27018 – Data Protection in the Cloud

ISO 27018 complements ISO 27001 and ISO 27017 with specific requirements for the protection of personal data in cloud services. It defines control mechanisms and policies to minimize data protection risks and ensure compliance with data privacy regulations. This certification is particularly relevant for companies processing personal data in the cloud and highlights our commitment to the highest data protection standards.

Status 2025/08/28

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